Status:
COMPLETED
A Phase I Study to Determine the Effect of Mifepristone on the Pharmacokinetics of Fluvastatin in Healthy Volunteers
Lead Sponsor:
Corcept Therapeutics
Conditions:
Healthy Subjects
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This study is to determine the effect of single and multiple oral doses of mifepristone on the pharmacokinetics of a single oral dose of fluvastatin administered to healthy volunteers.
Detailed Description
This is a fixed-sequence, drug-drug interaction study in healthy volunteers lasting up to a total of 9 weeks: up to 4 weeks screening, approximately 2 weeks for dosing (including a 1-week washout betw...
Eligibility Criteria
Inclusion
- Male or female healthy volunteers
- Body mass index (BMI) of 18-32 kg/m2
- Female subjects must have a negative serum pregnancy test result prior to entry into the study
- All female subjects must not be of child-bearing potential
- All male subjects with female partners of childbearing potential must consent to use a medically acceptable double-barrier method of contraception and not donate sperm throughout the study period and for at least 3 months (90 days) after the last dose of study medication
- The subject agrees to abstain from grapefruit or grapefruit juice for at least 2 weeks prior to the first dose and until completion of the pharmacokinetic sampling (Day 15)
- The subject must be able to provide written informed consent
Exclusion
- Any acute or chronic disease state, including but not limited to cardiovascular, dermatological, endocrine, gastrointestinal, hepatic, pulmonary, and renal conditions determined to be clinically significant by the Investigator
- Any clinically significant abnormal clinical laboratory tests as determined by the Investigator
- Any concomitant medications (including prescription, over-the-counter or illicit) within either 30 days or five half-lives (whichever is shorter) prior to dosing
- Positive urine drug screen for any illicit drugs
- Use of tobacco or any nicotine-containing products during the previous three months
- Grapefruit juice within two weeks prior to first dose
- Participation in a clinical investigation of any drug, biological or other investigational therapy within 30 days prior to dosing
- Signs and/or symptoms such as orthostatic hypotension, fatigue, anorexia, nausea, abdominal pain, joint and muscle pain if considered to be a marker of adrenal insufficiency
- History of an allergic reaction to mifepristone or fluvastatin
- Positive serum test for human immunodeficiency virus (HIV), hepatitis B virus or hepatitis C virus
- Blood donation within 30 days of dosing
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00752843
Start Date
September 1 2008
End Date
November 1 2008
Last Update
February 17 2012
Active Locations (1)
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1
MDS Pharma
Tempe, Arizona, United States, 85283